MedtechSourcebook

ARC PRECISION

Contract manufacturer · Isanti, MN

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
3011567699 (openFDA record; or search FDA's registration database)
FEI number
3011567699
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
Arc Precision (FDA owner/operator no. 10048923)
Registered address
24726 Ulysses Ct NE, Isanti, MN 55040
Contract listings
6 device listings, 6 product codes, first listed Mar 19, 2015
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
FZXGuide, Surgical, InstrumentClass IGeneral and plastic surgeryContract manufacturingNov 25, 2024
HRSPlate, Fixation, BoneClass IIOrthopedicContract manufacturingMar 19, 2015
HTCPliers, SurgicalClass IGeneral and plastic surgeryContract manufacturingNov 25, 2024
HTJGauge, DepthClass IOrthopedicContract manufacturingNov 25, 2024
HWRDriver, ProsthesisClass IOrthopedicContract manufacturingNov 25, 2024
LXHOrthopedic Manual Surgical InstrumentClass IOrthopedicContract manufacturingMar 27, 2019